This document provides details on the professional experience and therapeutic areas of expertise of John H. Carver. It lists his experience with various pharmaceutical compounds and medical devices for central nervous system disorders, gastrointestinal disorders, women's health, cardiovascular/pulmonary disorders, and biologics. It also outlines his roles providing field-based medical affairs and medical science liaison programs.

1. Professional Work Examples
Field Based Medical Affairs
and MSL Programs
John H. Carver, MSc. MBA.
Managing Director MedSci
For presentation to:
Dr. Robin Winter-Sperry
7-29-14

2. Therapeutic Space and Related Pharmaceutical
Compounds/Medical Devices/Biologics Experience
• Central Nervous System Disorders: Upjohn’s Xanax® (alprazolam), Solvay’s Luvox®
(fluvoxamine maleate), Lithobid® (lithium carbonate), Flesinoxan (the 5-HT1A
receptor agonist - (DU-29,373) investigational research only), Forest Labs Celexa®
(Citalopram HBr), Lexapro® (escitalopram oxalate), Campral® (acamprosate
calcium), Namenda® (memantine hydrochloride), Viibryd® (vilazodone HCl), H.
Lundbeck A/S Serdolect® (sertindole), and early pre-marketing engagement on
Arena’s 5Ht2c modulator Belviq® (lorcaserin HCI) for obesity management,
marketed by Vivus Inc., *Neuraceq™ (florbetaben F -18 injection) Neuraceq™ is a
radioactive diagnostic agent indicated for Positron Emission Tomography (PET)
imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients
with cognitive impairment who are being evaluated for Alzheimer’s Disease (AD)
and other causes of cognitive decline and is marketed by Piramal Imaging, a
division of Piramal Life Sciences.
• CNS Medical Device: Cyberonics Vagus Nerve Stimulation (VNS Therapy®), the
surgically implantable neurostimulator FDA class- III medical device indicated for
treatment of refractory epilepsy and treatment-resistant depression.
• * Neuraceq™ (florbetaben F -18 injection) is also listed under Biologics

3. Therapeutic Space and Related Pharmaceutical
Compounds/Medical Devices/Biologics Experience
• Gastrointestinal Disorders: Solvay’s Creon (pancrelipase), ROWASA® (Mesalamine)
Rectal Suspension Enema and Suppository, Asacol® (mesalamine) Delayed-Release
Tablets, Novartis Consumer Health’s Prevacid®24HR (lansoprazole delayed-release
capsules 15 mg/acid reducer Proton Pump Inhibitor (PPI)).
– GI Medical Device: Olympus Surgical Technologies Global: CW-II PCNL Intracorporeal Lithotripsy.
• Women’s Health and Reproductive Endocrinology: Solvay’s Estratest® (esterified
estrogens and methyltestosterone), Estratab® (esterified estrogens), Curatab®
(medroxyprogesteroneacetate(MPA)), Zenate® Pre-natal Vitamin Tablets, Columbia
Labs Crinone® (progesterone gel).
• Cardiovascular and Pulmonary: Forest Labs Tiazac® (diltiazem hydrochloride)
Extended-Release Capsules, Aerobid® (flunisolide) and Aerobid®-M Inhaler System,
Boehringer Ingelheim Aggrenox® (aspirin/extended-release dipyridamole) Capsules,
BROVANA® (arformoterol tartrate) Inhalation Solution.
• Medical Devices: Cybersonics OmniWave™ Ultrasonic Endovascular Thrombectomy
Device, C.R. Bard Peripheral Vascular’s FlowCardia™ CTO Crosser.

4. Therapeutic Space and Related Pharmaceutical
Compounds/Medical Devices/Biologics Experience
• Biologics: Alexion Pharmaceuticals infused biologic, Soliris® (eculizumab), in the
treatment of patients with atypical hemolytic uremic syndrome (aHUS) to
inhibit complement-mediated thrombotic microangiopathy and paroxysmal
nocturnal hemoglobinuria (PNH) to reduce hemolysis. Savient Pharmaceuticals
Krystexxa® (pegloticase), a PEGylated uric acid specific enzyme indicated for the
treatment of chronic gout in adult patients refractory to conventional therapy,
Novartis Vaccines and Diagnostics (NV&D) Menveo® [Meningococcal (Groups
ACY and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine]
solution for intramuscular injection. Neuraceq™ (florbetaben F -18 injection)
Neuraceq™ is a radioactive diagnostic agent indicated for Positron Emission
Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque
density in adult patients with cognitive impairment who are being evaluated for
Alzheimer’s Disease (AD) and other causes of cognitive decline and is marketed
by Piramal Imaging, a division of Piramal Life Sciences.

5. US Field Based Medical Affairs - MSL Team
Presentation Made to Client
MSL Program Update – State of the Team Report
Tuesday, 5/13/2014
CLIENT 1 EXAMPLE

6. State of the Team Report
• MSLs Currently
– Training
– Exposure to KOLs
– Time in the field
• Next steps in training
– Gap analysis
– Individual or group Remediation
• Next steps for outreach
– CMS-CED
– Neurologists
– Imaging Centers
• Current needs
– Ratification of CED Process
• Future needs
– TBD
H
C
A
D
Florbetaben Images for the
5-, 10-, and 20-min Scan
Duration Groups
Please note that the visual
assessment method for florbetaben
teaches the use of grayscale and
inverse grayscale, not color

7. CMS-CED Process

9. Policy
Number
Policy Name
PIR-0001 Scientific Information Exchange
PIR-0002 Unsolicited Request for Medical Information
PIR-0003 Adverse Event Reporting
Thought Leader and Key Opinion Leader Development
Thought Leader and Key Opinion Leader Identification & Support
Medical Conferences and Conventions
Procedures for Medical Information Booths
Travel and Expenses
Business Meals and Items of Value
PIR-0004 State Restrictions on Interactions with Healthcare Professionals
Commercial Collaboration
Investigator Initiated Studies (IIS, IIT)
Grants
Speaker Training
Promotional Speakers Program
Advisory Board and Consulting Agreements
Pharmacy and Therapeutics Committee Meetings
Providing Reimbursement Information to Customers and Patients
Patient Privacy
Medical Information Working Guidelines
Roles and Responsibilities of Medical Information Department
Developing Medical Information Responses
Fair Market Value
PIR-0005 OIG, AdvaMed and PhRMA Guidance
Medical Meeting Process
• SOP’s govern Field Based MSL
activities providing the proper
operational framework to ensure
Client and MSL safe-harbor.
• In the absence of an official client
provided Field Based Medical
Affairs MSL SOP, MSLs will operate
under and functionally within the
domain of CMO SOP’s.
• MSL SOP’s are written in a manner
which comply with all industry and
regulatory guidance, and provide
compliant direction and broad
stroke control over MSL related
activities.
First 5 MSL SOP’s

13. FBB MSL Home Study Training Compendium

18. US Field Based Medical Affairs - MSL Team
Presentation Made to Client
MSL Program Update – State of the Team Report
Brovana Launch Meeting
Thursday, 5/29/2014

19. MSL Deployment Analytics and Process
US Population Densities 2012
Aligning MSLs to Client Need is a Science.
In order to best map FBM-MSL Geographies, Knowledge of
Population Densities and COE must be part of the process.

20. MSL Deployment Analytics and Process
US Population Densities 2012

21. Client Provided IST-Overlay
MSL Deployment Analytics and Process
Tim Murphy,
Hartford
Sara Harris
Nashville
Ken Greenwald
Columbus
Harry Yesilevich
Chicago
Robbin Honbo
Los Angeles
Randy Richard
Dallas
Paul Klees
Seattle
Stacey Graninger
Phoenix
Brian Maas
Minneapolis
Chuck Draksler
Philadelphia
As of 1-6-14
Bobby Cabaniss
Orlando
Neil Boyce
Indianapolis
Jonas Lichty
Charlotte
Erica Mann
Buffalo
Pete Altieri
Baltimore
Vinny
DiRosa
Kansas City
Craig Counseller
Detroit
Kevin Dunn
Miami
Steve Wondrasch
Long Island
Steven Weeks
Newark
Dusty Menser
Louisville
Greg Irvin
Atlanta
Chip Bleiberg
Houston
Troy Haub
Tulsa
Monija Afzal
San Diego

22. IST-Overlay + PDM = Alignment x3 FBM-MSLs
MSL Deployment Analytics and Process Confirms Vertical
Boarder to Boarder Stratification Mapping
Tim Murphy,
Hartford
Sara Harris
Nashville
Ken Greenwald
Columbus
Harry Yesilevich
Chicago
Robbin Honbo
Los Angeles
Randy Richard
Dallas
Paul Klees
Seattle
Stacey Graninger
Phoenix
Brian Maas
Minneapolis
Chuck Draksler
Philadelphia
Bobby Cabaniss
Orlando
Neil Boyce
Indianapolis
Jonas Lichty
Charlotte
Erica Mann
Buffalo
Pete Altieri
Baltimore
Vinny
DiRosa
Kansas City
Craig Counseller
Detroit
Kevin Dunn
Miami
Steve Wondrasch
Long Island
Steven Weeks
Newark
Dusty Menser
Louisville
Greg Irvin
Atlanta
Chip Bleiberg
Houston
Troy Haub
Tulsa
Monija Afzal
San Diego

25. Headcount Mitigation Action Plan
• Phase-I: In an effort to deliver near-term strategic and tactical
MSL support and ensure stakeholder value recognition, we
will respond to and facilitate High Value requests for CDMA
commercial collaboration and support on a limited national
level, until such time we are able to hire, train, onboard, and
deploy the phased placement of the full x3 MSL Team.
7/29/2014 Scientific Advantage 25

26. Key Milestone Timeline

28. A beacon on the horizon providing safe harbor consulting services to US
Pharmaceutical and Medical Device sector enterprises. We help companies
navigate the ever changing currents within the medical affairs, legal,
regulatory, and compliance space.
CONFIDENTIALITY NOTICE: The information contained in this presentation is intended only for the exclusive review of the individual or entity named above and
may contain information that is privileged, confidential or exempt from disclosure under applicable law. If the above mentioned is not the intended recipient, or
the agent responsible for review, you are hereby notified that any dissemination, distribution or copying of these data is strictly prohibited.